-- Two SITC 2025 presentations: First-in-class dendritic cell $(DC)$ maturation agent Plinabulin drives immune re-sensitization in metastatic NSCLC patients who had progressed after PD-1/L1 inhibitors with disease control rate of 85% in combination with docetaxel and Keytruda. Mechanism studies with MD Anderson collaborators showed DC maturation and M1 macrophage polarization via a Plinabulin specific GEF-H1 dependent mechanism in responding patients with Plinabulin, PD-1 inhibitor and radiation. -- SEED, co-founded by BeyondSpring with 38% equity share, successfully completed its $30 million Series A-3 financing, alongside U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its lead program targeting RBM39. -- SEED Named Finalist for 2025 Prix Galien USA "Best Start-Up" Award
FLORHAM PARK, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. $(BYSI)$, a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today reported Q3 2025 financial results alongside clinical and corporate milestones.
"With over 700 patients treated, Plinabulin continues to demonstrate a favorable safety profile and meaningful potential as an immune-modulating therapy with unique mechanism of dendritic cell (DC) maturation and T cell priming," said Dr. Lan Huang, Co-Founder, Chair and Chief Executive Officer of BeyondSpring. "With DC bridging innate and adaptive immunity, Plinabulin offers new hope for patients with NSCLC and other cancers whose disease progresses after checkpoint inhibitors, presented at recent SITC conference. In addition, results from our global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, showed that Plinabulin in combination with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia, reinforcing its potential to advance the standard of care and drive long-term value creation."
Dr. Huang added, "At SEED, which we co-founded with Lilly five years ago, we are excited that our RBM39 molecular-glue degrader has received IND clearance from both the US FDA and China NMPA. It is such an honor to be the only target protein degradation company nominated by the Prix Galien Foundation, recognizing our commitment to developing transformative medicine for patients. We are also grateful for the support of our investors and collaborators, including Lilly and Eisai, and clinicians from leading US institutions, as we work together to advance molecular glue development to address undruggable targets for patients with unmet medical needs."
Key Milestones:
-- Two SITC 2025 Presentations on Plinabulin Anti-cancer Clinical Benefit:
-- Resensitize NSCLC Patients Who Progressed on Prior PD-1/L1
Inhibitors with Disease Control Rate of 85% in Phase 2 Clinical
Study: New data from a phase 2 investigator-initiated study
(NCT05599789, Peking Union Hospital China) evaluating Plinabulin,
docetaxel, and pembrolizumab in metastatic NSCLC patients who
progressed on prior PD-1/L1 inhibitors (n=47), showed encouraging
efficacy and safety data. The combination demonstrated median
progression-free survival $(PFS)$ of 7.0 months, confirmed objective
response rate $(ORR)$ of 18.2%, duration of response (DOR) of 7.2
months, disease control rate (DCR) of 85%, and 12-month overall
survival (OS) rate at 79%, and 24-month OS rate at 66% (median OS
not reached).
-- Resensitize Patients with Eight Cancer Types Who Failed Prior
PD-1/L1 Inhibitors with Disease Control Rate of 54% through DC
Maturation and M1 Macrophage Polarization via GEF-H1-dependent
Mechanism in Phase 1 Clinical Study: This phase 1
investigator-initiated study (NCT04902040, MD Anderdon Cancer
Center) shows that in addition to potent DC maturation for a
systemic immune response, plinabulin combined with radiation and
PD-1 inhibitor promotes proinflammatory monocytes and M1
macrophage polarization via a Plinabulin specific GEF-H1-dependent
mechanism with the potential of overcoming acquired resistance to
immune checkpoint inhibitors from pro-tumor macrophages.
-- SEED, Co-founded by BeyondSpring with 38% Equity Share, Secured Financial
Position and Achieved IND Clearance: SEED completed its $30 million
Series A-3 financing and received U.S. FDA and China NMPA clearance of
its Investigational New Drug (IND) application for its lead RBM39
degrader program. SEED was also named a finalist for the 2025 Prix Galien
USA "Best Start-Up" Award and co-hosted a targeted protein degradation
symposium at NYU Grossman School of Medicine honoring Co-Founder and
Nobel Laureate Prof. Avram Hershko, with leading thought leaders in the
TPD field as presenters.
Third Quarter Financial Results(1)
Continuing operations:
-- Research and development (R&D) expenses were $1.0 million for the quarter
ended September 30, 2025 compared to $0.6 million for the quarter ended
September 30, 2024. The $0.4 million increase was primarily due to higher
drug manufacturing expenses, higher professional service expenses in
regulatory affairs and higher volume of Plinabulin combination therapy
research to support strategic business development and partnership
initiatives.
-- General and administrative (G&A) expenses were $0.8 million for the
quarter ending September 30, 2025 compared to $1.7 million for the
quarter ended September 30, 2024. The $0.9 million decrease was primarily
due to lower professional service costs in consulting for business
development and partnership initiatives, and lower salary expenses driven
by decrease in administrative headcount.
-- Net loss: $1.7 million for the quarter ended September 2025, compared to
$2.2 million for the quarter ended September 2024
-- Cash and cash equivalents: $12.5 million as of September 30, 2025,
compared to $2.9 million as of December 2024
Discontinued operations:
-- Net loss: $3.2 million for the quarter ended September 2025, compared to
$2.4 million for the quarter ended September 2024
-- Current assets: $11.4 million as of September 2025, compared to $25.3
million as of December 2024
Year to Date Financial Results(1)
Continuing Operations:
-- Research and development (R&D) expenses were $2.9 million for the nine
months ended September 30, 2025 compared to $2.2 million for the nine
months ended September 30, 2024. The $0.7 million increase was primarily
due to higher drug manufacturing expenses, higher professional service
expenses in regulatory affairs, and higher volume of Plinabulin
combination therapy research to support strategic business development
and partnership initiatives.
-- General and administrative (G&A) expenses were $3.4 million for the nine
months ended September 30, 2025, compared to $4.9 million for the nine
months ended September 30, 2024. The $1.5 million decrease was primarily
due to lower salary expenses resulting from decrease in administrative
headcount, lower professional services in consulting for business
development and partnership initiatives, and lower company overhead
expenses mainly due to decrease in investor relations services and D&O
insurance related costs.
-- Net loss: $6.2 million for the nine months ended September 2025, compared
to $6.9 million for the nine months ended September 2024
Discontinued operations:
-- Net loss: $2.2 million for the nine months ended September 2025, compared
to $5.0 million for the nine months ended September 2024
Note 1: Accounting Update
Following definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED's financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 38% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED's outstanding shares.
About BeyondSpring
BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin's novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at beyondspringpharma.com.
About SEED Therapeutics
SEED Therapeutics is a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders to treat diseases driven by undruggable proteins. Its proprietary RITE3$(TM)$ platform enables targeted protein degradation with small-molecule precision. SEED's lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers. SEED's investors and collaborators include Eli Lilly and Eisai, both of whom have been instrumental in supporting SEED's mission to unlock undruggable disease targets. The company's pipeline includes nine programs across oncology, neurodegeneration, immunology, and virology. Learn more at seedtherapeutics.com.
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